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Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

18 Years
Not Enrolling
Sleep, Endometrial Neoplasms, Pain

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Trial Information

Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

Despite continuing improvements in surgical procedures and ancillary care, post surgery pain
continues to be a nearly universal patient experience following major operative procedures.
Opioids provide considerable pain relief, but they have multiple adverse side effects and
are not entirely effective. For cancer patients, uncontrolled postoperative pain can have a
substantial negative effect on quality of life, can slow recovery, increase the likelihood
of complications, and contribute to poorer postoperative outcomes. The identification of
novel modifiable patient risk factors for post surgery pain that could become the target of
presurgery interventions is thus an important goal. We will conduct a randomized,
placebo-controlled, double-blind intervention trial design to evaluate the effects of an FDA
approved hypnotic (zolpidem) on post surgery pain. Since presurgery psychological factors
(e.g., heightened anxiety) are known to predict the severity of post surgical pain and may
be associated with poor sleep, we will also assess psychological factors (with
questionnaires) as well as sleep (using actigraphy) in order to determine their individual
and combined impact on women's experiences of post surgery pain in this stressful clinical
context. Aim 1: To determine the impact of zolpidem administered the night prior to
endometrial cancer surgery on women's experiences of pain over the initial 7-10 day
follow-up period after surgery using a double-blind placebo-controlled design (final n=128).
Aim 2: To investigate psychological factors on the morning before surgery, as well as
objective sleep variables on the night before surgery, as possible mediators of the
beneficial effects of zolpidem on post surgery pain. Aim 3: To examine psychological
factors, as well as sleep variables, assessed prior to the sleep intervention as possible
moderators of the ameliorative effects of zolpidem on post surgery pain. The results of the
proposed exploratory study would provide the preliminary data necessary for an R01
application to support more comprehensive investigations, including explorations of
biological mechanisms underlying the preventative effects of better presurgery sleep on
patients' experiences of post surgery pain.

Inclusion Criteria:

- be women at least 18 years old

- have clinical indications of primary endometrioid adenocarcinoma of the endometrium

- be scheduled for staging surgery by laparotomy under standardized protocols

- have the ability to communicate in English sufficient for completion of study

- have no neuromuscular/ movement disorders (for actigraphy purposes)

- have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined
by their attending physician as part of clinical care)

- have no ongoing use of medication known to affect sleep or wake function (e.g.,
hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics,
decongestants, sedating antihistamines, beta blockers, corticosteroids)

Exclusion Criteria:

- have a history of previous or concomitant cancer

- have an estimated life expectancy of < 6 months

- will be admitted to the hospital prior to the day of surgery

- are unable to complete study measures

- are unable to provide meaningful informed consent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Brief Pain Inventory (Short-form)

Outcome Description:

Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery.

Outcome Time Frame:

at the clinical follow-up appointment approximately 7-10 days after surgery

Safety Issue:


Principal Investigator

Dana H Bovbjerg, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

April 2011

Related Keywords:

  • Sleep
  • Endometrial Neoplasms
  • Pain
  • Sleep
  • Endometrial Neoplasms
  • Pain
  • Neoplasms
  • Endometrial Neoplasms
  • Adenoma



Magee-Womens Hospital of UPMCPittsburgh, Pennsylvania  15213
UPMC MercyPittsburgh, Pennsylvania  15219